BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2121504 · Received May 6, 2011

    Report

    Report Number
    2027969-2011-01010
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULT PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 6.8, REFERENCE: 5.2, MEAN: 6.00, CONFIDENCE LIMITS: NA. THE 6.0 INR WAS EXCLUDED FROM COMPARISON TEST SINCE NO CORRESPONDING REFERENCE OR REPEATED INRATIO VALUE WAS PROVIDED. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. THE CALCULATED MEAN IS GREATER THAN 5.0 INR, BUT THE DIFFERENCE BETWEEN RESULTS IS LESS THAN 2.2. BOTH INR RESULTS ARE GREATER THAN 5.0. GENERALLY, INR RESULTS GREATER THAN 5.0 HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POINT-OF-CARE AND LABORATORY BASED PT TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE 62935, WHICH BRICK LOT #237418 WAS ASSIGNED AND PACKAGED INTO TWO STRIP LOTS (247450 AND 247451). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF (B)(4), NO FURTHER ACTION IS REQUIRED. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. THE ALLOWABLE DIFFERENCES BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WERE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES TESTED ON STRIP LOT #247451 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 6.0, LAB: NG. DATE: (B)(6) 2011, INRATIO: 6.8, LAB: 5.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 NI